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Product Regulation & Liability

Italy: The AIFA’s Report on timeline for pricing and reimbursement procedures

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In brief

On 27 April, the Italian Medicines Agency (AIFA) published on its website the Report on the Timelines of Pricing and Reimbursement Procedures (“P&R procedures“) of medicines during the period 2018-2022 (“Report“). The purpose of the Report is to ensure the principle of transparency of the administrative action and to inform citizens and economic operators about the timelines for access to reimbursed medicines.

Key takeaways 

Specifically, the Report indicates that the overall duration of the P&R procedures, running from the date of the beginning of the procedure to the date of its conclusion, including the period of evaluation by AIFA’s advisory committees, has decreased from 2018 to 2021 from an average of 10 to eight months for non-generic medicines and around two-three months for generic drugs.

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Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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